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Hip endoprosthesis shaft
Intended use
• Component of a human hip endoprosthesis: Hip endoprosthesis shaft
• Combination with Aesculap hip endoprosthesis components
• Implant range: BiCONTACT®, BiCONTACT® S, H, SD, or N and BiCONTACT®
Revision.
• Implantation without bone cement, for PLASMAPORE®-coated shaft
• Implantation with bone cement, for uncoated shaft
Materials
The materials used in the implant are listed on the package.
• ISOTAN®
titanium forged alloy Ti6Al4V according to ISO 5832-3
F
• ISODUR®
Cobalt-Chromium forged alloy CoCr29Mo according to
F
ISO 5832-12
• ISOTAN®
pure titanium, ISO 5832-2
P
• PLASMAPORE® surface coating made of pure titanium acc. to ISO 5832-2
or
PLASMAPORE®
surface coating made of pure titanium acc. to
µ-CaP
ISO 5832-2, with additional calcium phosphate coating
BiCONTACT®, ISOTAN®, ISODUR® and PLASMAPORE® are registered trade-
marks of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Use for acute disorders of the hip that cannot be treated with other therapies:
• Degenerative osteoarthritis
• Rheumatic arthritis
• Fractures of the joint
• Femoral head necrosis
Risk of aseptic implant loosening when using
bone cement with uncoated BiCONTACT® pros-
thesis shafts made of ISOTAN®.
Do not use uncoated BiCONTACT® prosthesis
shafts made of ISOTAN® (titanium forged
WARNING
alloy ISO 5832-3) for implantations with
bone cement.
Exceptional indications: Patients with proven foreign-body sensitivity for the
alloy elements nickel, cobalt or chromium where a prosthesis shaft anchoring
with bone cement is indicated at the same time.
Indications in cases of interventions to replace hip endopros-
thesis shafts, for the shaft type BiCONTACT® Revision
• Cement-free revision operations
• Periprosthetic fractures
• Subprosthetic fractures
• Treatment of large bone defects on the proximal femur
Contraindications
Implant failure due to excessive body weight of
the patient and mainly distal fixation of the small
BiCONTACT® implants!
Avoid distal implant fixation by appropriate
femoral bone preparation.
WARNING
Bore up the distal marrow cavity, using flexi-
ble marrow cavity drills.
Ensure sufficiently deep prosthesis seat
through proximal-medial support.
Carry out intraoperative check of the prosthe-
sis seat, using an imaging device.
In case of distal implant fixation observe maximum body weight of the
patient: 50 kg for NK709T and NK710T (BiCONTACT® SD sizes 9 and 10),
60 kg for NJ208T, NJ209T, NJ210T (BiCONTACT® D sizes 8,9 and 10) and
65 kg for NK210T (BiCONTACT® Revision SD size 11).
Do not apply in the presence of:
• Possibility of reconstructive interventions for the treatment of the joint
illness, e.g. osteotomic resetting
• Acute or chronic infections near the joint, or systemic infections
• Secondary diseases that could influence joint implant functionality
• Systemic diseases and metabolic disturbances
• Acute osteoporosis or osteomalacia
• Severely damaged bone structures that could prevent stable implantation
of implant components
• Bone tumor in the region of implant fixation
• Bone malformations, defective axial positioning, or other bone conditions
that rule out implantation of a hip-joint prosthesis
• Anticipated excessive load on the joint implant
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
Contraindications for interventions to replace hip endopros-
thesis shafts
The replacement of an endoprosthetic implant is a difficult intervention sub-
ject to individual conditions.
• To arrive at a decision on whether to provide such replacement, the oper-
ating surgeon must assess and, if necessary, consider the contraindica-
tions with regard to the success of the intervention.
Side-effects or adverse interactions
• Changes in position, loosening, wear and tear on, or fracture of implant
components
• Joint dislocation and postoperative changes in leg length
• Primary and secondary infections
• Venous thrombosis, lung embolism, and cardiac arrest
• Tissue reaction to implant materials
• Injury to vessels and nerves
• Hematoma and impaired wound healing
• Periarticular calcification
• Decreased joint mobility and flexibility
• Arthralgia and decreased tolerance for exercise
When using the prosthesis shaft BiCONTACT® Revision:
• Secondary operation to remove the distal locking screw (if applicable)
Safety information
• The implant components were tested and approved for use in combina-
tion with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• Proper surgical performance of the implantation is the responsibility of
the operating surgeon.
• General risk factors associated with surgical procedures are not described
in the present instructions for use.
• The operating surgeon must have a thorough command of both the
hands-on and conceptual aspects of the established operating tech-
niques.
• The operating surgeon is responsible for combining and implanting the
implant components, with or without bone cement.
• The operating surgeon must be thoroughly familiar with bone anatomy,
including the pathways of nerves, blood vessels, muscles and tendons.
• Aesculap is not responsible for any complications arising from incorrect
diagnosis, choice of incorrect implant, incorrectly combined implant
components and/or operating techniques, the limitations of treatment
methods, or inadequate asepsis.
• The instructions for use of the individual Aesculap implant components
must be observed.
• Under no circumstances should damaged components or surgically
excised components be used.
• Implants once used must not be reused.
• The implant components applied, along with their article numbers, the
name of the implant, as well as the lot number and serial number (if avail-
able) must be documented in all patient records.
• During the postoperative phase, in addition to mobility and muscle train-
ing, it is of particular importance that the physician keep the patient well
informed.
• Damage to the weight-bearing bone cement and/or bone structures can
give rise to loosening of the components, fracture of the bone or implant,
as well as to other grave complications.
• To ensure the earliest possible detection of such catalysts of implant dys-
function, the prosthetic joint must be checked periodically, using appro-
priate techniques.
• Only combine modular implant components with the appropriate
Aesculap hip endoprostheses.
• Observe material, friction coupling diameter and cone specifications.
• Note further restrictions on combined implants.
• Avoid damaging the implant, especially in the neck or cone region, by
applying instruments (e.g. HF surgical devices) close to the implant.
Risk of implant component breakage due to
combination with implant components from other
manufacturers!
Use Aesculap implant components only.
CAUTION
Sterility
• The implant components come individually packed in protective packag-
ing that is labeled according to its contents.
• The implant components are sterilized by irradiation (minimum dose
25 kGy).
Store implant components in their original packaging and only remove
them from such packaging immediately before use.
Prior to use, check the product expiration date and verify the integrity
of the sterile packaging. Do not use implant components that are past
their expiration dates or whose packaging is damaged.
Sterilization method and parameters
Sterilize with steam, taking note of the following:
The sterilization has to be done according to a validated steam steriliza-
tion procedure (e.g. in a sterilizer in conformance with EN 285/ANSI/
AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993, and validated in con-
formance with EN 554/ISO 13683). In case of application of the frac-
tionated vacuum procedure the sterilization has to be carried out for a
minimum of 5 minutes at 134 °C and at 2 bar pressure.
Implants made of non-coated metal may be individually resterilized in steam
following appropriate preliminary cleaning and disinfecting.
Make sure the implant mechanism is not damaged during cleaning and
resterilization.
Prosthesis cone protection caps that are labeled accordingly can be resteril-
ized with steam.
If the resterilization of ceramic implants should become necessary, fol-
low the directions in the relevant Aesculap instructions for use.
The responsibility for resterilization of implant
components lies with the end-user. Such resteril-
ization is expressly prohibited by law in certain
countries (e.g. France).
Never resterilize or reuse surface-coated
WARNING
implants
(PLASMAPORE®
PLASMAPORE®
µ-CaP
Application
The operating surgeon draws up an operation plan that specifies and accu-
rately documents the following:
• Selection of the implant components and their dimensions
• Positioning of the implant components in the bones
• Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
• All requisite implant components must be ready to hand
• Operating conditions must be highly aseptic
• The implantation instruments, including the special Aesculap implant
system instruments, must be complete and in working condition.
• The operating surgeon and operating room team must be thoroughly con-
versant with the operating technique, as well as the range of implants
and instruments to be applied; complete information on these subjects
must be readily available at the workplace.
• Those performing operations must be thoroughly conversant with the
rules governing medical practice, the current state of scientific knowl-
edge, and the contents of relevant articles by medical specialists from the
professional literature.
• In case of an ambiguous preoperative situation and if an implant is
already present in the joint region to be provided for, information was
sought from the manufacturer.
The operative procedure has been explained to the patient, and the latter's
understanding of the following information has been documented:
• The functionality of the prosthetic joint is essentially inferior to that of
the natural one.
• The prosthetic can bring about only limited improvement in the patient's
condition vis-à-vis their condition prior to the operation.
• The prosthetic joint can become loose owing to excessive load, wear and
tear, or infection.
• The lifespan of the prosthetic joint depends on the body weight and the
load put on the joint.
• The prosthetic joint must not be subjected to overload through extreme
strain, or through work-related or athletic activities.
• Corrective surgery may be necessary if the implant becomes loose.
• In the event corrective surgery is performed, under certain circumstances
it may not be possible to restore joint mobility and flexibility.
• The revision of a hip endoprosthesis shaft is a complex joint-replacement
operation; it is generally inferior to the primary joint replacement.
• The patient must have their physician carry out follow-up examinations
of the prosthetic joint at regular intervals.
The implantation and implantation site are prepared in the following way:
Having performed the head osteotomy and opened the marrow cavity,
finish the femur with BiCONTACT®-specific A- and B-osteoprofilers.
Carry out intraoperative orientation of the implant components. When
doing this, pay attention to the resection line and the trochanter wing.
Select the implant according to B-osteoprofiler last introduced in the
correct position.
Before inserting the implants, carry out a test reposition and examine
joint mobility, joint stability and leg length.
WARNING
Do not under any circumstances allow the implant surface to be dam-
aged.
Ensure that the cone sizes of the prosthesis shafts and the prosthesis
heads match (see cone size on the implant packaging, e.g. 12/14 or 8/
10).
Only remove the protective cap from the prosthesis cone immediately
before setting the prosthesis head in place.
Rinse, clean and dry the outside cone of the shaft and, if necessary, the
inside cone of the prosthesis head prior to setting the prosthesis head in
place.
Couple the prosthesis head and cone at room temperature only. If nec-
essary, allow the implant to cool to room temperature.
Prepare and apply bone cement as described in the instructions for use
provided by the cement supplier.
If a distal centralizer is used with the cemented BiCONTACT® prosthesis
shaft: Follow the instructions for use for the Aesculap centralizer.
Before closing the wound, ensure, if necessary by means of an image
converter, that the implant components are correctly positioned.
In order to forestall abnormal wear and tear on the prosthesis: Remove
any loose bone cement or bone chips before closing the wound.
When carrying out interventions to replace hip endoprosthesis shafts of the
type BiCONTACT® Revision, the following instructions must be observed:
Prepare the marrow cavity with A and B reamers if you are going to
remove the implant through a proximal access (if necessary with an
additional bone window). Pay attention to the reamer marking and size
according to the planned prosthesis size and length.
When preparing the marrow cavity, work the reamers manually, taking
care to remove as little bone substance as possible.
If necessary, finish the marrow cavity preparation with B-osteoprofilers
and conclude by implanting a BiCONTACT® revision shaft.
If the primary stability is not sufficient (axial fit and rotation), carry out
distal locking. Use special aiming or/and image amplification device for
this purpose.
Use Aesculap 5-mm locking screws for locking. Follow the instructions
for use of the locking screws.
Transfemoral access:
When operating through a transfemoral access, lock the BiCONTACT®
revision shaft.
Use A-reamers to prepare the distal fitting of the prosthesis. When doing
this, keep to a distal anchoring length of at least 100 mm.
WARNING
and
).
Note
The BiCONTACT® revision shafts are locked for the primary stabilization of the
prosthesis shaft in cases of severe bone defects. The distal force transmission
via the locking screws is designed to be a device for temporary stabilization.
Further information on B. Braun/Aesculap implant systems is readily avail-
able from B. Braun/Aesculap or the B. Braun/Aesculap office responsible.
TA-Nr.: 010238
Bone fractures in the implant site reduce the via-
bility of the implant anchorage.
Avoid bone fractures through careful opera-
tive techniques.
Treat bone fractures with appropriate intra-
and postoperative therapies.
Handle the implant components properly.
Risk of locking screw breakage due to permanent
distal force transmission!
Remove the locking screws after 1 to 2 years
(reference period), depending on bone
remodeling and integration of the revision
implant in the proximal bone fraction. The
appropriate timing of this intervention
depends on the individual patient's situation;
it can be later in cases of delayed bone
remodeling.
12/09
Änd.-Nr.: 32607
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